Johnson & Johnson Announces Groundbreaking Nipocalimab Study Of Pregnant Individuals At High Risk For Early Onset Severe Hemolytic Disease Of The Fetus And Newborn Published In The New England Journal Of Medicine

Author: Benzinga Newsdesk | August 07, 2024 05:41pm

Nipocalimab delayed or prevented severe fetal anemia and 54 percent of study participants in the Phase 2 UNITY study achieved a live birth at or after 32 weeks without the need for intrauterine transfusion (IUT)

The AZALEA Phase 3 clinical study is currently enrolling patients: Nipocalimab is the only therapy in clinical development for use in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN)

SPRING HOUSE, Pa., Aug. 7, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the results from the Phase 2 open-label UNITY study of nipocalimab for the treatment of alloimmunizeda pregnant individuals at risk of early onset severe (EOS) HDFN have been published in The New England Journal of Medicine (NEJM). The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT.1 Nipocalimab is currently the only therapy reported to be in clinical development for HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the developing fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.2 These results showed that nipocalimab delayed or prevented severe fetal anemia requiring treatment prenatally and reduced the need for IUTs in pregnancies at high risk for recurrent EOS HDFN.1 

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